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Xynomic Pharma Has Acquired Worldwide Rights of Abexinostat

On February 24, 2017 Xynomic Pharmaceuticals, Inc., an oncology drug research and development company, reported that it has acquired exclusive worldwide rights to develop, manufacture and commercialize Abexinostat, a potentially best-in-class innovative HDAC inhibitor targeting hematological and solid tumors (Press release, Xynomic Pharmaceuticals, FEB 24, 2017, View Source [SID1234527688]).

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To date a total of 17 Phase 1 and 2 clinical trials of Abexinostat in US, EU and Asia have already been completed, demonstrating that Abexinostat is clinically active in multiple tumor settings with a more favorable safety profile among HDAC products. Xynomic aims to initiate Phase 3 registrational trials worldwide in Q3’2017.

"We are honored and excited to forge this landmark agreement. We will deploy necessary resources and closely work with KOLs to expeditiously bring this innovative drug to the market to address unmet medical needs," said Mr. Y. Mark Xu, Co-Founder, Chairman and CEO of Xynomic.

TRILLIUM THERAPEUTICS PROVIDES ADDITIONAL DETAILS ON ASCO-
SITC CONFERENCE PRESENTATION ON TTI-621

On February 24, 2017 Trillium Therapeutics Inc. (NASDAQ/TSX: TRIL), a clinical-stage immuno-oncology company developing innovative therapies for the treatment of cancer, reported new pharmacology data from its ongoing Phase 1 a/b trial of TTI-621, a SIRPaFc fusion protein targeting CD47 in patients with advanced hematologic malignancies (Filing, 6-K, Trillium Therapeutics, FEB 24, 2017, View Source [SID1234517990]). The presentation took place at the ASCO (Free ASCO Whitepaper)-SITC Clinical Immuno-Oncology Symposium in Orlando, Florida.

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The company presented the following new information from the trial:

Receptor occupancy increases with multiple infusions of TTI-621, conferring robust CD47 blockade on circulating leukemic cells: Compared to the initial infusion, the extent and duration of CD47 occupancy on peripheral leukocytes was elevated following the sixth dose. Importantly, emerging data suggests increased receptor occupancy on circulating leukemic blast cells. The level of target engagement achieved is associated with strong phagocytosis activity of tumor cells in vitro.

Increases in cytokines associated with macrophage activation suggest rapid engagement of the innate immune system: Post-infusion elevations were observed in MIP-1a, MIP-1b and other cytokines associated with macrophage activation, supporting the proposed role of TTI-621 as an innate immune checkpoint inhibitor.

Transient thrombocytopenia due to target mediated clearance is attenuated subsequent to the first infusion of TTI-621: Additional data has clarified that the transient thrombocytopenia observed following TTI-621 exposure is often diminished after multiple infusions. This suggests that there may be an opportunity to increase TTI-621 exposure in patients after the initial dose.

Weekly infusions lead to a longer half-life and accumulation of circulating drug, overcoming the platelet antigen sink: After six infusions the terminal half-life of TTI-621 increased to 3.7 days with an attendant rise in circulating drug trough levels, which is consistent with the half-lives of many marketed Fc fusion proteins. Drug accumulation was accompanied by stable pre-dose platelet counts, suggesting that multiple infusions of TTI-621 overcome the platelet antigen sink.

"This recently expanded data set markedly advances our understanding of TTI-621’s pharmacological properties, and exemplifies the emerging nature of this exciting development program," said Dr. Niclas Stiernholm, Trillium’s Chief Executive Officer. "These latest results suggest that we overcome the antigen sink and achieve meaningful TTI-621 exposure while maintaining acceptable platelet counts. We are excited to continue the exploration of this unique checkpoint inhibitor in patients with multiple types of blood cancers, as well as in patients with solid tumors."

The ASCO (Free ASCO Whitepaper)-SITC poster presentation on TTI-621 can be found on the company’s website at www.trilliumthera

First Half 2017 Operational Update

On February 24, 2017 Prima BioMed Ltd (ASX: PRR; NASDAQ: PBMD) reported an update to shareholders on recent developments with the company regarding active clinical trials, current partnership developments, and cash reach in conjunction with the release of the Half Year report for the period ended 31 December 2016 (Filing, Q2, Prima Biomed, 2017, FEB 24, 2017, View Source [SID1234517894]).

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Clinical Trial Updates: IMP321
Prima is pleased to announce the following updates on our clinical applications of IMP321:
AIPAC (Active Immunotherapy PAClitaxel), completed the safety-run in phase in December 2016. The randomized phase started in January 2017 with 30 mg of IMP321 as the recommended phase 2 dose. First patients have been recruited and we plan to open further clinical sites in the near term to ramp up the patient recruitment. In total, the trial aims to recruit up to 226 patients in a randomized, placebo-controlled, double blind setting.

TACTI-mel (Two ACTive Immunotherapeutics in melanoma), our Australian melanoma trial is progressing well with the first patient cohort of this Phase 1 dose escalation study completed in December 2016. The second cohort, receiving 6 mg of IMP321, is underway and already 4 out of 6 patients have been successfully treated; no dose limiting toxicity has yet been reached. The open label, Phase 1 study is designed to recruit 18 patients and anticipated to be fully recruited in the third quarter of 2017. Patients with unresectable or metastatic melanoma that have had a suboptimal response to KEYTRUDA are being dosed with IMP321 in combination with KEYTRUDA and there should be multiple data readouts throughout 2017.

A data update – including efficacy of all 15 patients from the safety-run in phase of AIPAC (open label) is expected to be published in mid-2017.

Financials
As a result of careful financial management, Prima remains in a solid financial position with approximately $15.5M cash as of mid-February 2017. Based on our forecast, the current operational cash reach has been extended to end of first quarter calendar year 2018.

TRILLIUM THERAPEUTICS PROVIDES ADDITIONAL DETAILS ON ASCO-SITC CONFERENCE PRESENTATION ON TTI-621

On February 24, 2017 Trillium Therapeutics Inc. (NASDAQ/TSX: TRIL), a clinical-stage immuno-oncology company developing innovative therapies for the treatment of cancer, reported new pharmacology data from its ongoing Phase 1 a/b trial of TTI-621, a SIRPaFc fusion protein targeting CD47 in patients with advanced hematologic malignancies (Press release, Trillium Therapeutics, FEB 24, 2017, View Source [SID1234517831]). The presentation took place at the ASCO (Free ASCO Whitepaper)-SITC Clinical Immuno-Oncology Symposium in Orlando, Florida.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The company presented the following new information from the trial:

Receptor occupancy increases with multiple infusions of TTI-621, conferring robust CD47 blockade on circulating leukemic cells: Compared to the initial infusion, the extent and duration of CD47 occupancy on peripheral leukocytes was elevated following the sixth dose. Importantly, emerging data suggests increased receptor occupancy on circulating leukemic blast cells. The level of target engagement achieved is associated with strong phagocytosis activity of tumor cells in vitro.

Increases in cytokines associated with macrophage activation suggest rapid engagement of the innate immune system: Post-infusion elevations were observed in MIP-1a, MIP-1b and other cytokines associated with macrophage activation, supporting the proposed role of TTI-621 as an innate immune checkpoint inhibitor.

Transient thrombocytopenia due to target mediated clearance is attenuated subsequent to the first infusion of TTI-621: Additional data has clarified that the transient thrombocytopenia observed following TTI-621 exposure is often diminished after multiple infusions. This suggests that there may be an opportunity to increase TTI-621 exposure in patients after the initial dose.

Weekly infusions lead to a longer half-life and accumulation of circulating drug, overcoming the platelet antigen sink: After six infusions the terminal half-life of TTI-621 increased to 3.7 days with an attendant rise in circulating drug trough levels, which is consistent with the half-lives of many marketed Fc fusion proteins. Drug accumulation was accompanied by stable pre-dose platelet counts, suggesting that multiple infusions of TTI-621 overcome the platelet antigen sink.

"This recently expanded data set markedly advances our understanding of TTI-621’s pharmacological properties, and exemplifies the emerging nature of this exciting development program," said Dr. Niclas Stiernholm, Trillium’s Chief Executive Officer. "These latest results suggest that we overcome the antigen sink and achieve meaningful TTI-621 exposure while maintaining acceptable platelet counts. We are excited to continue the exploration of this unique checkpoint inhibitor in patients with multiple types of blood cancers, as well as in patients with solid tumors."

The ASCO (Free ASCO Whitepaper)-SITC poster presentation on TTI-621 can be found on the company’s website at www.trilliumtherapeutics.com. Additional information about this clinical trial of TTI-621 is available at www.clinicaltrials.gov using identifier: NCT02663518.

Oxford BioMedica Notes Encouraging Results of the Investigator Led Phase I/II clinical trial of MVA-5T4 Immunotherapy (TroVax®) and Low Dose Cyclophosphamide in Patients with Advanced Colorectal Cancer

On February 24, 2017 Oxford BioMedica plc (LSE:OXB) ("Oxford BioMedica" or "the Group"), a leading gene and cell therapy group, reported the results from a Phase I/II clinical trial of MVA-5T4 immunotherapy (TroVax) and low dose cyclophosphamide (CPM) in patients with advanced colorectal cancer (TaCTiCC) (Press release, Oxford BioMedica, FEB 24, 2017, View Source [SID1234517827]). A poster was presented by the clinical investigators in a poster session at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and Society for Imumunotherapy of Cancer (ASCO-SITC) Clinical Immuno-Oncology Symposium on 23 February 2017 in Orlando, USA.

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The poster described the open-label Phase I/II clinical trial involving 53 patients with inoperable, metastatic colorectal cancer who were randomised to receive either no treatment, low dose CPM, TroVax only or low dose CPM followed by TroVax. The primary study endpoint was to assess increased anti-5T4 responses after treatment on day 43 and the secondary endpoints were progression free /overall survival and anti-5T4 responses over the trial period.

The study findings demonstrated that significant anti-5T4 immune responses were generated at treatment day 43. Secondary analysis revealed that both CPM and TroVax independently induced highly beneficial anti-tumour immune responses, resulting in significant survival of end stage colorectal cancer patients, without any major toxicity. This was the first randomised study to show a benefit of immunotherapy in advanced colorectal cancer patients.

Commenting on the results, John Dawson, Chief Executive Officer of Oxford BioMedica, said: "The presentation by the Clinical Investigators of the Phase I/II TaCTiCC study at the ASCO (Free ASCO Whitepaper)-SITC Clinical Immuno-Oncology symposium showed the potential benefit that Oxford BioMedica’s immunotherapy (TroVax) treatment could give to patients with advanced colorectal cancer."